Fifth Non-Small Cell Lung Cancer Vaccine Candidate Phase II Study Launched

Ultimovacs ASA announced yesterday that the first patient had been randomized in the LUNGVAC phase 2 clinical study in Norway.

This is the fifth Phase II clinical trial in which the universal cancer vaccine, UV1, is being investigated in combination with checkpoint inhibitors.

Topline data read-out from LUNGVAC is anticipated by the end of 2024.

The LUNGVAC study in non-small cell lung cancer (NSCLC) is designed to assess the impact of UV1 in combination with standard-of-care immunotherapy, the anti-PD1 checkpoint inhibitor pembrolizumab.

In four Phase I trials involving 82 patients, UV1 has maintained a positive safety and tolerability profile and has demonstrated encouraging signals of efficacy. 

"LUNGVAC addresses one of the world's largest cancer indications, and we have designed the trial to test if UV1 in combination with pembrolizumab can improve the treatment of patients with unmet needs," said Jens Bjørheim, Chief Medical Officer of Ultimovacs, in a press release on October 25, 2022.

Lung cancer is one of the most common cancers globally, and NSCLC accounts for approximately 85% of all lung cancers, with the squamous form of NSCLC being particularly difficult to treat.

The LUNGVAC study is focused on a subset of NSCLC patients with adenocarcinoma or squamous tumors, where at least half of the tumor cells express the PD-L1 antigen, and who have not previously received pembrolizumab treatment. 

These subgroups represent approximately 1/3 of all advanced and metastatic NSCLC patients.

Professor Odd Terje Brustugun, the study's principal investigator, commented, "The evaluation of UV1 and pembrolizumab is an important next step in changing the standard of care for patients with non-small cell lung cancer. We look forward to working with Ultimovacs to reach our mutual goal."

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase.

It is being developed as an "off-the-shelf" therapeutic cancer vaccine for use in combination with other immunotherapies that require an ongoing T cell response for their mode of action.

The U.S. FDA previously granted Fast Track designation to UV1 as add-on therapy to ipilimumab or pembrolizumab for the treatment of unresectable or metastatic melanoma, as well as Orphan Drug designation to UV1 for the treatment of stage IIB – IV melanoma.